|
Design History Files and Technical Files under US FDA and EU MDD
This medical device compliance training will be helped to see how to understand the similarities and differences of these two complimentary documents and how to comply with the respective requirements and develop compliant files to address.
Description
The U.S. FDA’s Design Control requirements of the QS Regulation mandate the initiation and maintenance of a product Design History File for products to be marketed in the U.S. The European Union’s Medical Device Directive and a company’s Notified Body require a Technical Dossier or Technical File to show compliance to the Essential Requirements of the MDD and associated relavant standards for product to be CE-marked and marked in those countries (and others). Attendees will be helped to see how to understand the similarities and differences of these two complimentarty documents. Attendees will be further helped to comply with the respective requirements and develop compliant files to address either or both.
Areas Covered in the seminar:
- The U.S. FDA’s DHF’s defined purpose;
- The EU’s MDD’s defined purpose;
- Similarities;
- Differences;
- Parallel approaches to developing the documents;
- When to involve teams;
- What to expect from FDA and NB audits;
- Approaches to ensure they remain “living (and useful) documents”.
Who will benefit:
- Senior management, project leaders
- Regulatory affairs
- Quality systems personnel:FDA and ISO / MDD / CE-marking compliance
- R&D and engineering staff
- All charged with new product development, regulatory submissions, initiating / overseeing regulatory compliance.
Instructor Profile:
John E. Lincoln, consultant, has successfully designed, written over 50 ISO 14971-compliant Risk Management Files / Reports, including FMECA and FTA analysis, many in response to FDA 483 observation, which have subsequently passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development / design control projects; with over 24 years of experience, primarily in the medical device industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP.
|
